From food science to manufacturing, biotechnology is a very broad field that can refer to technological applications that use biological systems, living organisms, or derivatives thereof, to make or modify products or processes. In discussing such an expansive topic, the U.S. biotechnology community has found it helpful to categorize the broader field into three major areas:

Agriculture/Aquaculture

Medical/Healthcare

Industry/Environment

In the area of agriculture and aquaculture, biotechnology applications are focused on meeting increasing global food and fuel needs with increased crop yields, decreased crop inputs (e.g. water and fertilizer) and pest control methods, and with improved environmental impacts. Meeting participants agreed that existing efforts adequately cover this area and there is little need for solutions to be developed by the International Organization for Standardization (ISO), especially as this is a highly regulated field.

Medical and healthcare applications capitalize on the attributes and capabilities of cells and use biological molecules like DNA and proteins to develop vaccines, regenerative medicine, and molecular diagnostics. Although this category is highly regulated in certain countries and regions, some standardization activities for medical and healthcare biotechnology applications have taken place and more may be possible.

Participants identified the industry and environment category as the area with the greatest potential for international standardization. From cellulosic fibers and the remediation of oil spills to the production of biofuels and bio-based plastics, this biotechnology application uses micro-organisms and enzymes to improve manufacturing processes.

Presentations given during the January 10 meeting are publicly available for download (.zip file) and review.

Based on the valuable input provided by the biotechnology experts, ANSI staff prepared a position for presentation during the January 21-22, 2008, meeting of the ISO Council Standing Committee on Strategies (ISO CSC/STRAT).

Confirming that biotechnology is a subject of interest to ISO, the Committee agreed to approach the subject over an 18-month period, pending formal approval by ISO Council in March 2008.

In the near term, ISO staff and ISO Council member countries will collect information on biotechnology standards at the international (both inside and outside ISO), regional and national levels to develop a comprehensive listing and portfolio analysis of existing work. The ISO CSC/STRAT agreed to organize this cataloging activity according to the three broad subfields outlined above.

At its October 2008 meeting, the ISO CSC/STRAT will review the comprehensive listing/portfolio analysis, refine the categorization of subfields as necessary, and identify a possible limiting of the scope of ISO’s consideration of biotechnology standards. Following the meeting, ISO member bodies will conduct national consultation processes on the need for ISO biotechnology standards, using the comprehensive listing/portfolio analysis as a basis for these consultations.

During the first quarter of 2009, the ISO CSC/STRAT will examine the results of the national consultation processes, and will form an expert task force to develop final recommendations for the ISO Council’s consideration and action at its September 2009 meeting.

The ISO CSC/STRAT also considered the possibility of an ISO International Biotechnology Standards Workshop to be held in early to mid-2009, following the national consultation processes.

As ISO proceeds to take these biotechnology standardization issues under consideration, ANSI will continue its dialogue with the established group of U.S. biotechnology experts, beginning with the comprehensive listing and portfolio analysis of existing standards.

For more information about biotechnology standardization activities in the U.S. or to express interest in the listing and analysis effort, please contact Mr. Steven Cornish, ANSI director of international policy (212.642.4969; scornish@ansi.org).